STOCK OF THE WEEK- PREVENTION BIO- $8.08
- ARTICLE IN NY TIMES ON THIS COMPANIES PRODUCT-
- ABILITY TO SPOT STAGE 1 BEFORE IT HAPPENS AND DELAY...
- IT IS GOING TO BE HARD TO FIND PATIENTS <---- WE ALMOST NEED A DIAGNOSTIC TOOL IN HAND WITH THIS BUT.... $$$$$$$$$
Provention Bio price target raised to $30 from $24 at Chardan 10:17 PRVB Chardan analyst Geulah Livshits raised the firm's price target on Provention Bio to $30 from $24 and keeps a Buy rating on the shares after teplizumab gained FDA approval as the first treatment to delay the onset of Stage 3 type 1 diabetes in adult and pediatric patients aged eight years and older with stage 2 diabetes. There is "nothing too surprising about the label," Livshits tells investors in a research note. The analyst adjusted his model to reflect the approval, pricing, and a more conservative penetration for the present based on the higher than expected price.
F.D.A. Approves a Drug That Can Delay Type 1 Diabetes
The therapy will cost nearly $200,000. But it’s the first treatment in 100 years to alter the course of the disease, which usually begins in adolescence.
The drug, marketed as Tzield, does not cure or prevent diabetes, but delays its onset by an average of two years and, for some patients, much longer.Credit...Provention Bio
Nov. 18, 2022
The
Food and Drug Administration has approved the first treatment that can delay — possibly for years — the onset of Type 1 diabetes, a disease that often emerges in teenagers.
The new drug, teplizumab, is made by Provention Bio, which will partner with Sanofi to market the drug in the United States under the brand name Tzield. In an investor call on Friday, Provention said the drug would cost $13,850 a vial or $193,900 for the 14-day treatment. The company said teplizumab should be available by the end of the year.
The drug, which the F.D.A. approved on Thursday, does not cure or prevent Type 1 diabetes. Instead, it postpones its onset by an average of two years and, for some lucky patients, much longer — the longest so far is 11 years, said Dr. Kevan Herold of Yale, a principal investigator in trials of the drug.
The only other treatment for the disease — insulin — was discovered 100 years ago and does not affect the course of the disease. It just replaces what is missing.
The treatment prolonged the period in which they made some insulin, but eventually all got diabetes.
In 2011, Dr. Bluestone and Dr. Herold proposed a different sort of study. They would treat people who were at high risk of diabetes but who had not yet developed it. It was a bold move, Dr. Bluestone noted. “Other than vaccines, there aren’t many drugs given before diagnosis,” he said.
To find those people, the researchers worked with a group of clinical trial sites, TrialNet, that were supported by the National Institutes of Health. Dr. Herold is now the group’s chairman. TrialNet investigators screened 200,000 people who were immediate family members of people with Type 1 diabetes, looking for antibodies indicating an immune attack on the pancreas and abnormal glucose metabolism.
The result was a
study, published in The New England Journal of Medicine, that led to Thursday’s approval.
test people can order, underwritten by the foundation. But, Dr. Kowalski said, “we want pediatric offices to do it.”
Testing also offers another opportunity, he said. It turns out that antibodies indicating an immune attack often occur when people are as young as 5 or 6 years old, although most do not develop diabetes until they are teenagers.
Now, he said, his hope is to treat people even earlier, as soon as those antibodies emerge. Clinicians and the F.D.A. had previously objected to treating before the disease was clearly underway, asking, “How can you give an immunotherapy if they are normal?” Dr. Kowalski said.
But, he said, the antibodies tell a different story.
“They do have diabetes,” he said, although not according to the usual definition of the disease. “It just hasn’t unmasked itself yet. We need to help them save their beta cells,” the insulin-secreting cells of the pancreas.